Confidential & Restricted Circulation

LOGO XX PHARMACEUTICALS LIMITED

117 Adams Street, Brooklyn, NY 11201, USA

USER REQUIREMENT SPECIFICATION (URS)

URS No.: Revision no.:

Title: User Requirement Specification (URS) >for<Specific Equipment/Instrument Name>

USER REQUIREMENT SPECIFICATION (URS)

FOR
< SPECIFIC EQUIPMENT/INSTRUMENT NAME>

URS NO.:
REVISION NO. :
ADDENDUM NO. :

FACILITY:
PRODUCTION DEPARTMENT
XX PHARMACEUTICALS LIMITED
117 Adams Street, Brooklyn, NY 11201, USA
 Confidential & Restricted Circulation

LOGO XX PHARMACEUTICALS LIMITED

117 Adams Street, Brooklyn, NY 11201, USA

USER REQUIREMENT SPECIFICATION (URS)

URS No.: Revision no.:

Title: User Requirement Specification (URS) >for<Specific Equipment/Instrument Name>

LIST OF REVISION

Revision No. Reason for Revision Issue date

 Confidential & Restricted Circulation

LOGO XX PHARMACEUTICALS LIMITED

117 Adams Street, Brooklyn, NY 11201, USA

USER REQUIREMENT SPECIFICATION (URS)

URS No.: Revision no.:

Title: User Requirement Specification (URS) >for<Specific Equipment/Instrument Name>

LIST OF ADDENDUM

Addendum No. Reason for Addendum Issue date

 Confidential & Restricted Circulation

LOGO XX PHARMACEUTICALS LIMITED

117 Adams Street, Brooklyn, NY 11201, USA

USER REQUIREMENT SPECIFICATION (URS)

URS No.: Revision no.:

Title: User Requirement Specification (URS) >for<Specific Equipment/Instrument Name>

TABLE OF CONTENTS

Sr. No. Contents Page No.

 Confidential & Restricted Circulation

LOGO XX PHARMACEUTICALS LIMITED

117 Adams Street, Brooklyn, NY 11201, USA

USER REQUIREMENT SPECIFICATION (URS)

URS No.: Revision no.:

Title: User Requirement Specification (URS) >for<Specific Equipment/Instrument Name>

LIST OF ABBREVIATIONS
 Confidential & Restricted Circulation

LOGO XX PHARMACEUTICALS LIMITED

117 Adams Street, Brooklyn, NY 11201, USA

USER REQUIREMENT SPECIFICATION (URS)

URS No.: Revision no.:

Title: User Requirement Specification (URS) >for<Specific Equipment/Instrument Name>

1.0 SIGNATURE PAGE:

Prepared By

Department Designation Signature & Date

Reviewed By
Department Designation Signature & Date

Approved By

Department Designation Signature & Date

 Confidential & Restricted Circulation

LOGO XX PHARMACEUTICALS LIMITED

117 Adams Street, Brooklyn, NY 11201, USA

USER REQUIREMENT SPECIFICATION (URS)

URS No.: Revision no.:

Title: User Requirement Specification (URS) >for<Specific Equipment/Instrument Name>

2.0 SCOPE:

2.1 Scope of the URS is to define for the specific Equipment/Instrument.

3.0 PROCEDURAL DOCUMENT REQUIREMENTS

This part gives information about the Equipment/Instrument including Purpose of the Equipment,

Specification, Qualification etc.

3.1 Name of the Equipment

Name of the equipment to be mentioned here, if possible, Model No. to be define here.

3.2 Purpose of the Equipment

Purpose of the Equipment shall be clearly defined here.

3.3 Number of Equipment Required

Require quantity of the Equipment/Instrument shall be define here.

3.4 Qualification

List of qualification document shall be mentioned here.

3.5 Specification of Equipment

All major specification of the Equipment/Instrument shall be mentioned here.

 Confidential & Restricted Circulation

LOGO XX PHARMACEUTICALS LIMITED

117 Adams Street, Brooklyn, NY 11201, USA

USER REQUIREMENT SPECIFICATION (URS)

URS No.: Revision no.:

Title: User Requirement Specification (URS) >for<Specific Equipment/Instrument Name>

4.0 OPERATIONAL REQUIREMENTS

4.1 Vendor Scope

The Vendors scope shall include the Supply, Installation, Documentation including calibration

certificates, User training, Details of service / maintenance contracts available

4.2 Operation

Basic operative characteristics including Data logging (21 CFR part 11), controlling system, capacity,

safety and protection, capacity of basic function etc.

4.3 Options and Ancillaries

The vendor should identify, where applicable, their standard equipment that fits this specification.

The vendor shall (where possible) also provide costs including, A range of additional maintenance

support and services., Any additional accessories to fulfil the requirements indicated in section 4.2.

4.4 Interfaces

A user-friendly control system is required, that can allow system operation with a minimal amount of

training.

4.5 Data and Security

If require, data and security article to be clearly define here.

4.6 Environment

Instruments/Equipment’s operating environment should be clearly defined here. Operating area must

be fit with the specific Instruments/Equipment’s in such a way that it can be operate without any

difficulty.
 Confidential & Restricted Circulation

LOGO XX PHARMACEUTICALS LIMITED

117 Adams Street, Brooklyn, NY 11201, USA

USER REQUIREMENT SPECIFICATION (URS)

URS No.: Revision no.:

Title: User Requirement Specification (URS) >for<Specific Equipment/Instrument Name>

5.0 CONSTRAINTS

5.1 Milestones and Timelines

A projected timeline and milestone may be set here.

5.2 Compatibility and Support

The internal components of the system must be compatible with, and resistant to, the materials used

during operation. Operating power to be mentioned here.

5.3 Maintenance Requirements

The manufacturer should supply details of any maintenance / breakdown packages available.

5.4 Procedural Constraints

6.0 LIFE CYCLE

6.1 Development Procedures

Future development procedure to be mentioned here.

6.2 Testing Requirements

See Section 11 for a detailed matrix of the validation testing requirements.

6.3 Delivery Requirements

On supply the following documentation should be supplied: Operation and maintenance manual
(including manufacturer’s recommendations for maintenance schedules). Calibration certificates.

Parts list and spares requirements. System specifications.

6.4 Support

The vendor must supply details of all service and maintenance requirements of the equipment. The

vendor must also supply details of any service and maintenance support that they can supply.
 Confidential & Restricted Circulation

LOGO XX PHARMACEUTICALS LIMITED

117 Adams Street, Brooklyn, NY 11201, USA

USER REQUIREMENT SPECIFICATION (URS)

URS No.: Revision no.:

Title: User Requirement Specification (URS) >for<Specific Equipment/Instrument Name>

7.0 GMP REQUIREMENT

List of cGMP requirement shall be mentioned here.

8.0 UTILITIES AVAILABLE AT THE SITE OF INSTALLATION

Utilities shall be described here including power supply for the machine/equipment’s.

9.0 DOCUMENTATION REQUIREMENT

List of documents shall be described here such as Operation, cleaning, and maintenance manuals for

equipment as well as the operation, Installation instructions/ guideline, other drawings (such as

Mechanical, electrical, instrumentation etc.), IQ/OQ documents & operating manual., Instrument

calibration / Qualifications certificates traceable to the national reference standards, Guaranty/

warranty certificates for the equipment, Shipping checklist, Hardware design specification.

10.0 TERMS AND CONDITIONS TO BE INCLUDED IN THE QUOTATION

All the terms and conditions shall be described here.

11.0 DISCUSSIONS/ REVIEW/ COMMENTS

All the discussion shall be noted here and contact personnel details shall be mentioned at the end of

the discussion details.

12.0 ANNEXURES

Mention annexures if there is any.

 Confidential & Restricted Circulation

LOGO XX PHARMACEUTICALS LIMITED

117 Adams Street, Brooklyn, NY 11201, USA

USER REQUIREMENT SPECIFICATION (URS)

URS No.: Revision no.:

Title: User Requirement Specification (URS) >for<Specific Equipment/Instrument Name>

13.0 VALIDATION REQUIREMENTS

The following details the test requirements for documentation, testing and the stage of the project at which
they must be provided/performed. These requirements are a minimum tariff, and the vendor is required to
include any documentation, not already requested here, which are considered necessary to support
successful validation of the system.

Test Stage
Test Requirements
Impact
Tender assessment/ IOQ
Installation

Example Calibration Certificates Y

Documentation and
System Technical Specification Y
drawings Vendor to
supply the specified
documentation as a Operation and Maintenance
Y
minimum Manual

Calibration Certificates Y

Operational Testing Testing which demonstrates that

the equipment operates a
Y
Precise, Accurate, and
reproducible manner

Parts List and Spares

Y
requirements